Field of the Invention
The present invention relates generally to medical diagnostics using an ingestible medical diagnostic device, i.e. pill endoscopy.
Background Art
Endoscopes are commonly used by physicians to obtain images of internal tissues and organs as a diagnostic tool. Typically an endoscope is used to probe from a patient's mouth down into the upper gastro intestinal (GI) tract. During a colonoscopy, endoscopes are used to probe from the anus up into the lower GI tract. An endoscope is essentially a tube with a light and camera at its tip. Images can be transmitted outside the patient's body either optically (fiber optic cable), or converted by a camera to a digital signal and sent by wire up the endoscope and into an electronic device outside the patient.
Images presented to the physician are seen from the point of view described, i.e. looking down a tube. As a result of a complex folding of the GI tract and in combination with a fairly short distance for image capture due to low levels of lighting and/or low resolutions at far distances, only a short section of the GI tract can be viewed at any given time during an invasive procedure based on the location of the endoscope.
The population of the United States is aging. The first wave of the 78 million “Baby Boomers” is beginning to turn 60 years old. Coinciding with this aging of population is a rising concern regarding the public health, and a generally more educated patient in technology awareness. There has been an explosion in diabetes cases, estimated at 194 million cases worldwide today, and predicted to be 350 million cases by year 2025. Obesity currently affects two thirds of the U.S. population. There is a rising incidence of cardiac problems for women (the #1 cause of death for women). Hepatitis C will soon reach epidemic levels, infecting nearly 5 million people, more than the number of approximately 1.2 million people infected with HIV/AIDS in the U.S. Celiac disease affects approximately 3 million people in the U.S., with about 97% being undiagnosed. The prevalence of further serious conditions, such as cancer, ultra- or ulcerative-colitis, lactose intolerance, allergies, etc., indicate that there is a need for simple and easy diagnostic techniques, especially because many of these diseases are chronic, requiring repeat testing over time. Some conditions, such as cancer, are most responsive to treatment if caught in the early stages. Cancer, for example, is best detected in the digestive tract. Given that cancerous growth can occur in as little as one to two years, it is essential to detect cancer or cancerous precursors at least annually, or preferably biannually. Physician and health care resources are currently already stretched and will fail if the current technology, process and procedure are not altered to suit the needs of the baby boomer market of the near future. Time-saving and simple solutions to testing are needed.
The current population desires speedy testing and fast answers to their health questions. Many current testing and monitoring systems are limited by old technology and processes that take days, if not weeks, for results. These test methods, if not inconvenient and potentially embarrassing, are at least in most cases intrinsically painful or risky to patients.
One ingestible diagnostic device in the market today is a disposable RF camera pill or capsule camera, which captures images of the digestive tract as it passes through. Current camera pill usage by patients and physicians is limited for several reasons. First and foremost, current technology is very large in comparison to most ingestible medicines and nutritional supplements. The excessive size is in part a result of the selection of power-inefficient communication methods. The large size mandates pre-screening of patients (an additional process, inconvenience, and cost). The large size also leads to a reasonably high potential that the device can become lodged within the GI tract. This may lead to a highly invasive surgical removal requirement, which carries all the risks associated with some surgeries.
Conventional RF camera pills require a bulky reading device worn as a belt around the waist and adhesive sensors attached to the body to capture an electromagnetically-coupled signal transmitted from the pill. The patient is required to report to a physician's office for prescreening, to initiate use of the camera pill, and to be fitted with the belt reader. The belt reader is worn for 24 hours, during which time the camera pill captures images and transmits the images to the reader belt. At the end of a diagnosis period, the patient (and belt reader) must return to the physician. The physician downloads images from the belt reader and analyzes the images. The physician may analyze the images and discuss the results with the patient at yet another appointment during a subsequent visit. Thus, current RF camera pills require at least two trips to the physician's office, as well as the wearing of a cumbersome belt reader with leads attached to the skin.
This diagnostic process is both inconvenient and uncomfortable. It also carries a risk of surgical removal, due to the size of the current camera pills. Current technology does not offer a recorded position within the body associated to the specific image taken. Physicians must achieve a location of an image of interest through yet another procedure. Furthermore, the current camera pills are expensive devices, and are resorted to when other bowel disease diagnostic techniques, such as endoscopy and colonoscopy (each of which are extremely intrusive), present results that need further investigation. Further, the electromagnetic signals used to transmit the images may harm the sensitive tissue they pass through in order to be detected outside the body. Therefore, the current ingestible camera pill has significant deficiencies.
Current technology RF camera pills attempt to mimic the imaging carried out by physicians using laparoscopes and endoscopes. The camera pill illuminates the GI tract as it passes through and takes pictures at regular intervals, much like frames of a movie. The physician later views a series of images in a format of a movie that when paused appear much like images provided by an endoscope. Due to the natural movement of the digestive tract, the resultant movies from the current camera pills depict spurts of forward and backward movements that are awkward and not reviewer friendly, leading to issues of reviewer focus and overall system effectiveness.
What is needed is a way to display a high resolution image captured by a new generation of ingestible image scanning pills to a medical professional in a manner that allows the professional to easily find, zoom in on and get context for any abnormalities that may be observed.